None listed
Conditions
Brief summary
Mild traumatic brain injury (mTBI) or concussion results in persistent post-concussion symptoms (pPCS) in 31% of cases, contributing to lasting disability and significant cost burden. Evidence of efficacy of treatments for pPCS is scant and most individuals do not have access to evidence-based and timely treatment. There is a growing awareness that physical (e.g., vestibular, cervical), psychological (anxiety, fear avoidance) and medical factors interact in a variable fashion to perpetuate pPCS and need to be addressed in treatment. Mild TBI Guidelines recommend multidisciplinary treatment for pPCS. Evidence for the efficacy of such interventions remains limited. Our team co-designed and piloted an Interdisciplinary Rehabilitation program for Concussion Recovery (i-RECOveR), modifying it in response to consumer feedback. This led to a current randomised controlled trial funded by MRF2016112 (Ponsford CIC) (ACTRN12622000702718) of co-ordinated interdisciplinary treatment (neuropsychology, physiotherapy, medical) delivered in person. However, access to specialised interdisciplinary treatments is limited in rural/remote areas and public sector hospitals. Telehealth can increase access to such treatments for rural/remote residents, although evidence for telehealth concussion interventions is not established. With the aim of improving long-term outcomes after mTBI we will evaluate the efficacy of the i-RECOveR interdisciplinary intervention delivered to individuals with pPCS across Australia via telehealth, extending our pilot telehealth trial (ACTRN12624000924550) and its comparative effectiveness with our existing in-person delivery (ACTRN12622000702718). Our team will partner with individuals with pPCS including those in rural/remote areas, to evaluate the experience of receiving the intervention in-person and via telehealth and experiences of clinicians delivering it. The project will assess outcomes including symptom reduction, functional goal attainment of daily activities and quality of life, providing robust evidence of the effectiveness of this interdisciplinary model in addressing pPCS. A process evaluation will assess treatment integrity and content, participant experience, and cost effectiveness.
Interventions
All participants will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician via telehealth. Participants will be posted equipment packs to facilitate physiotherapy treatment via telehealth, including heart rate monitor, paddle pop sticks, laminated pages with numbers and checkers, and a ruler. All participants will receive 3 initial 60–90-minute consultations independently with a neuropsychologist, physiotherapist, and medicine physician. Telehealth will be facilitated using online video conferencing. Following initial consultations, clinicians will meet via video conference to discuss individualised treatment plans. Participants will then be offered up to an additional 7 sessions each of neuropsychology, physiotherapy, and medical treatment as required (i.e., including initial consultations, up to 24 sessions in total across the disciplines will be available based on clinical need). Telehealth treatment sessions will be delivered online via videoconference. Psychological treatment sessions will last between 60-90 minutes at a maximum of once a week. Physiotherapy treatment sessions will last for 45-60 minutes and will be at a maximum of once a week. Participants will also be offered ongoing medical management/review/consultations as required over the 8-week program. The psychological intervention will be oriented toward a cognitive-behavioural framework as described by Beck (1979) and will be adapted from previous manuals developed by Ferguson and Mittenberg (1996) and Silverberg et al. (2013) and will comprise of goal setting and review, psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, cognitive compensation intervention and sleep intervention. As part of this therapy, participants will be provided with educational materials adapted from readily available resources (published materials such as the Mild Head Injury Bookelet; https://www.monash.edu/medicine/psych/merrc/resources) as well as provided with material specially designed for this study. Participants will also be assessed by a physiotherapist and will be provided treatment in the following domains as required: ocular, vestibular, cervical, and autonomic system functioning. Physical therapy intervention will be specific to their assessment and may comprise of vestibular rehabilitation, manual therapy, cervical strengthening, proprioceptive training, and a graded exercise program. Examples of ocular retraining include convergence exercises where participants will watch a target as it moves towards them, saccadic retraining where participants quickly move their gaze between targets, and smooth pursuit training where the participant watches a moving target. Examples of vestibular rehabilitation are gaze stabilisation where participants turn their head and focus on a target (this is done to a particular speed predetermined by the physiotherapy assessing the participant), VOR cancellation exercises where participants watch a target move through space by turning their whole body, and motion sensitivity exercises such as, walking, and gaze stabilisation or VOR cancellation. Examples of cervical rehabilitation include cervical strengthening such as deep neck flexor strengthening, and proprioception training with a target and a laser to rehabilitate sensory awareness of the neck. Graded exercise is defined as exercise of the participant's choice that can be safely done for 20 minutes. Exercise will be targeted at a particular heart rate. The starting heart rate will be defined as 85% of the point of failure of the subject on Montreal Virtual Exertion test. Heart rates will increase in line with a decrease in participant's symptoms. This will be assessed and closely monitored by the physiotherapist. Graded exercise will generally be walking, running or stationary bike, however, other modes such as swimming could be introduced if tolerated and preferred by the participant. The physiotherapist will outline an individualised treatment and home program based on the assessment. Equipment used throughout the assessment and rehabilitation include various targets (a paddle pop, sticky labels), balls for motion sensitivity and a heart rate monitor for tracking heart rate. Medical management of persistent post-concussion symptoms will comprise of one consultation (same as initial consultation) with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school). Treatment fidelity: Adherence to the manualised CBT intervention will be rated by an independent psychologist who will listen to audio/video recordings of 10% of the sessions. To assess physiotherapy treatment fidelity, 10% of the sessions will be rated by an independent physiotherapist.
Sponsors
Study design
Eligibility
Inclusion criteria
(a) aged 16 –70 years, (b) sustained mTBI classified using American Congress of Rehabilitation Medicine criteria (ACRM):(31) (c) experiencing 3 or more PCS rated 2 or more over 2 weeks on RPQ (32); (d) >two weeks post-injury, <two years post-injury, (e) sufficient English, (f) reside in a Modified Monash Model classification area 2-6 (Australian Statistical Geography Standards for Remoteness) (g) have access to computer or tablet with an Internet connection that has sufficient bandwidth for videoconferencing.
Exclusion criteria
Current acute psychiatric condition, active substance abuse, significant neurological history, and insufficient English.